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David Hutton of Ophthalmology Times talks with Brian Strem, PhD, CEO Kiora Pharmaceuticals, about their recent partnership with Théa Open Innovation and further development of their KIO-301 and KOI-104 programs.
David Hutton of Ophthalmology Times talks with Brian Strem, PhD, CEO Kiora Pharmaceuticals, about their recent partnership with Théa Open Innovation and further development of their KIO-301 and KOI-104 programs.
Editor's note - This transcript has been edited for clarity.
I'm David Hutton of Ophthalmology Times. I'm joined today by Dr. Brian Strem, CEO of Kiora Pharmaceuticals. The company recently announced a strategic partnership with Théa Open Innovation. Tell us about this partnership and its importance for the company.
Absolutely, David. First and foremost, thank you for for having me on today. It's always a pleasure to reconnect.
So the deal with Théa that we just recently announced is really transformational for Kiora. Théa is a group [with] obviously, you know, hundreds of years of experience. And there's no joke in that. The family that started ... actually the French Ophthalmology Society back in the late 1800s, is the same family that is involved in owning and running Théa, which is a private French company. They clearly have a global footprint, or at least in the Western world, and a group that had expressed a lot of interest in our KIO-301 program. And it's novel, let's just call it, simplistically elegant approach to vision restoration using a small molecule.
So after, you know, obviously a long discussion with them, as with, you know, most parties in the space, we came upon an agreement to partner up, whereby we can now leverage a lot of their internal expertise, and then hand off the baton to them to hopefully commercialize our KIO-301 asset. Not just retinitis pigmentosa, which is our primary or first indication we're pursuing, but potentially other inherited retinal diseases or even age related retinal degenerations.
The company also announced securities purchase agreements. Can you tell us a little bit about this?
Absolutely. So there was clearly an opportunity here, and a lot of excitement around this type of a partnership, and what it means for the company and the validation behind the approach as well as the data that we've generated so far. And so we reached out to a handful of fundamental healthcare investors, groups like ADAR1, Velan, Stonepine, Nantahala, Rosalind, some phenomenal fundamental groups, and let them know what we were doing. And very quickly, they said, yes, we would like to help further shore up your balance sheet.
Not just the 301 asset, which obviously kind of semi found a home, even though there's still a lot of upside opportunity in milestones and royalty payments around that partnering structure, but also in one of our other assets that we haven't really talked much about. Because in the past, we've been a little bit limited in terms of where we can really spend the resources that we had. And with 301, that clearly took the majority of that activity.
And now we have the opportunity to really put our foot back on the accelerator of our KIO-104 program, which is a small molecule DHODH inhibitor, which is a class of an immunomodulatory targets, if you will, that already have multiple approved therapeutics for systemic treatments of things like RA and MS. But what we have is an ophthalmic formulation of a new molecule, or a new chemical entity, that we believe in the data so far is showing a lot of support around its ability to really modulate certain retinal inflammatory diseases that are really driven by proliferation and proliferative activity. Primarily of TH1 and TH17, CD4 cells. So one of the cell types or a few of the cell types that are heavily involved in a lot of the retinal inflammatory diseases, including posterior noninfectious uveitis, and potentially PVR, Proliferative Vitreoretinopathy, as well as some other inflammatory diseases.
Where's 104 in the clinical trial process.
104 has now completed two ophthalmic clinical trials to date, one for back of the eye, and one for the front of the eye actually. And what we're intending to do now is move this into a phase 2b clinical trial, which likely will be kicking off later this year, and probably in Europe, or Australia, or potentially both.
And what's next for development of 301?
Yeah, so 301, We are, you know, now working with our partner, and really getting ready for our ABACUS-2 phase 2 clinical study. This will be a randomized controlled trial that will involve two different dosing cohorts.
And the big difference versus our ABACUS-1 study, which was an open label study and a [single] unilateral injection is that this current study is going to be a bilateral, so both eyes will get injected. It will have monthly injections for three consecutive months. And then again being able to compare that against a control group to really now decipher and move away from any potential noise, if you will, of placebo responses and truly understand, you know, to the degree of of efficacious response.
Is there anything else in the Kiora pipeline that you can provide an update on?
No, those are really the two assets that that we are active in. Obviously, we are always keeping our eyes and ears open. So if there is an exciting approach that we think we can leverage our very efficient business model of getting to quick and reliable clinical data, and then backfilling a lot of the non clinical packages required.
That's something that we will absolutely, you know, take a look at, but our priority is 100% on, or at least shall I say 99%, on working with our partner Théa on our 301 program, as well as moving our 104 program forward
Aside from your own projects, what in the pharma side of ophthalmology really excites you today?
Yeah, so I tend to look more for areas of high unmet need. And you know, what doesn't really excite me, are, you know, some of just taking the same API and trying to deliver it a different way for the same diseases. Where I like to play, where I think there's going to be a lot of opportunity in the next 5 to 10 years, is one of the areas in neuro protection.
So there's a lot of other therapeutic spaces, like some ALS research, stroke research, that have some really interesting neuro protective assets that are currently working their way through clinical development. You know, the idea of being able to deploy some of those into the eye, which has some overlapping biology, I think could be really exciting and, frankly, patients either with inherited retinal diseases that lead to retinal degeneration, or age-related, or even things like glaucoma, where we know that neurons die, and because of that death, patients lose their vision. So can we start to take from some other therapeutic areas, some of these interesting approaches and apply them to the eye.